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Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.

Primary Purpose

Uveitis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Paracentesis of the anterior chamber
Sponsored by
The Eye Center and The Eye Foundation for Research in Ophthalmology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uveitis focused on measuring flaremetry, aqueous proteins, clinical grading, Compare flaremetry readings with the protein content of the aqueous, Compare flaremetry readings with clinical grading of flare

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 10 patients with uveitis with cataract
  • 10 patients without uveitis with cataract
  • Inactive inflammation for at least 3 months

Exclusion Criteria:

  • Infectious uveitis
  • endophthalmitis
  • cases with corneal scar

Sites / Locations

  • The Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients with uveitis

patients without uveitis

Arm Description

Paracentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery

Paracentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery

Outcomes

Primary Outcome Measures

compare flaremetry readings with the protein content of the aqueous humor
Compare flaremetry readings with the protein content of the aqueous and the clinical grading.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2013
Last Updated
August 29, 2014
Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
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1. Study Identification

Unique Protocol Identification Number
NCT01905579
Brief Title
Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Official Title
Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.
Detailed Description
A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
flaremetry, aqueous proteins, clinical grading, Compare flaremetry readings with the protein content of the aqueous, Compare flaremetry readings with clinical grading of flare

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with uveitis
Arm Type
Experimental
Arm Description
Paracentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery
Arm Title
patients without uveitis
Arm Type
Experimental
Arm Description
Paracentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Paracentesis of the anterior chamber
Intervention Description
Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.
Primary Outcome Measure Information:
Title
compare flaremetry readings with the protein content of the aqueous humor
Description
Compare flaremetry readings with the protein content of the aqueous and the clinical grading.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 10 patients with uveitis with cataract 10 patients without uveitis with cataract Inactive inflammation for at least 3 months Exclusion Criteria: Infectious uveitis endophthalmitis cases with corneal scar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir S Shoughy
Organizational Affiliation
THE EYE CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye Center
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25175512
Citation
Shoughy SS, Elkum N, Tabbara KF. Aqueous protein level and flare grading. Acta Ophthalmol. 2015 Mar;93(2):e173-4. doi: 10.1111/aos.12522. Epub 2014 Aug 31. No abstract available.
Results Reference
derived

Learn more about this trial

Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.

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